Mindfulness Training in the Medical Health Care System

The purpose of this study is to look at how mindfulness-informed emotional intelligence training may influence how participants think, feel, and act.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stress; Burnout, Professional; Emotion Regulation
• Intervention / Treatment: Behavioral: Search Inside Yourself (SIY) program

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ekaterina Denkova, PhD; Phone Number: 305-284-8148; Email: exn67@miami.edu

Study Locations

• United States
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • McLaren Health Care Corporation
      • Contact: Chandan Gupte; Phone Number: 810-342-1148
      • Principal Investigator: Amishi Jha, PhD
      • Principal Investigator: Ekaterina Denkova, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individuals who are between 18 and 80 years of age
2. Individuals who are fluent English speakers
3. Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection
4. Individuals who are willing and able to consent to participate in the study

Exclusion Criteria:

1. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness training group; Participants will receive 4 weeks of mindfulness-based training and then continue to have access to the mindfulness training exercise throughout the second training interval.	Behavioral: Search Inside Yourself (SIY) program; The present project involves the delivery of the Search Inside Yourself (SIY) program. The SIY Program is organized into 6 thematic modules. The first module introduces mindfulness and emotional intelligence and provides scientific evidence for the benefits of practicing mindfulness. The second module introduces Self-Awareness. The remaining four modules cover other domains based on Daniel Goleman's original framework of Emotional Intelligence: self-management, motivation, empathy, and leadership. Each module is associated with a set of practices, such as focused attention, body scan, journaling, empathic listening, and a Leadership Commitment exercise. The program will be delivered over 4 weeks, with one 3-hour session per week for a total of 12 hours that will take to complete all the modules.
Active Comparator: Wait-list Control Group; Participants will not receive 4 weeks of mindfulness-based training during the first training interval; they will receive 4 weeks of mindfulness training during the second training interval.	Behavioral: Search Inside Yourself (SIY) program; The present project involves the delivery of the Search Inside Yourself (SIY) program. The SIY Program is organized into 6 thematic modules. The first module introduces mindfulness and emotional intelligence and provides scientific evidence for the benefits of practicing mindfulness. The second module introduces Self-Awareness. The remaining four modules cover other domains based on Daniel Goleman's original framework of Emotional Intelligence: self-management, motivation, empathy, and leadership. Each module is associated with a set of practices, such as focused attention, body scan, journaling, empathic listening, and a Leadership Commitment exercise. The program will be delivered over 4 weeks, with one 3-hour session per week for a total of 12 hours that will take to complete all the modules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Positive Affect	Positive Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Positive has a range of scores from 5 to 25, with a higher score indicating a higher positive mood.	Baseline, up to 11 weeks
Change in Negative Affect	Negative Affect is assessed with the 5-item positive sub-scale from Positive and Negative Affect Schedule (PANAS). PANAS Negative has a range of scores from 5 to 25, with a higher score indicating a higher negative mood.	Baseline, up to 11 weeks
Change in Perceived Stress	Perceived stress is assessed with the 4-item Perceived Stress Scale (PSS-4). PSS-4 has a range of scores from 0 to 16, with a higher score indicating a higher level of perceived stress.	Baseline, up to 11 weeks
Change in Decentering	Decentering is assessed via the 11-item decentering sub-scale of the experience questionnaire (EQ-D). The decentering score ranges from 1 to 55, with a higher score indicating a higher level of decentering.	Baseline, up to 11 weeks
Change in Leadership Self-Awareness	Leadership Self-Awareness is assessed with the 4-item self-awareness sub-scale from the Authentic Leadership Questionnaire (ALQ). Each item is rated on a 5-point Likert Scale ranging from 0 ("not at all") to 4 ("frequently"), and higher scores indicate greater self-awareness.	Baseline, up to 11 weeks
Change in Workplace Emotional Intelligence	Workplace Emotional Intelligence is assessed with the 16-item Workplace Emotional Intelligence Profile Scale (WEIPS). Each item is rated on a scale from 1("strongly disagree") to 7 ("strongly"), and higher scores indicate greater emotional intelligence.	Baseline, up to 11 weeks
Change in Mindfulness	Mindfulness is assessed with the 15-item short version of the Five Factor Mindfulness Questionnaire (FFMQ). The scores range from 15 to 75 with higher scores indicating greater levels of mindfulness.	Baseline, up to 11 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Attentional Performance	The Sustained Attention Response Task (SART) is used to assess attentional performance and mind wandering (i.e., off-task thinking which is typically self-generated and compromises the performance of the task at hand). SART has a range of scores from 0 to 1 with a higher score indicating better accuracy when completing the task.	Baseline, up to 11 weeks
Change in Depression and Anxiety	Depression and anxiety is assessed with the 4-item Patient Health Questionnaire (PHQ-4) Each item is rated from 0 ("not at all") to 3 ("nearly every day"), and ratings are summed together. PHQ-4 has a range of scores from 0 to 12, with higher scores indicating higher levels of depression and anxiety.	Baseline, up to 11 weeks
Change in Burnout	Burnout will be assessed with the 12-item Burnout Assessment Tool (BAT-12). Each item is rated on a 5-point Likert scale from 0 ("never") to 5 ("always"). Ratings are then averaged on a scale of 0 to 5, where a higher score indicates greater burnout.	Baseline, up to 11 weeks
Change in Flourishing	Flourishing will be assessed using the 8-item Flourishing Scale. Each item is rated on a 7-point Likert scale from 0 ("Strongly disagree") to 7 ("Strongly agree"). Ratings are then averaged with higher scores representing greater psychological resources and strengths.	Baseline, up to 11 weeks
Change in Sleep	Sleep problems will be assessed with one question assessing the overall quality of the participants' sleep. The item is rated on a 4-point Likert scale. Scores range from 0 to 3 with a higher score indicating lower quality sleep.	Baseline, up to 11 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Amishi Jha, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Stress; Occupational Diseases; Burnout, Psychological; Burnout, Professional
• Other Study ID Numbers: 20230690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No